Section 100 – Highly Specialised Drugs Program

The Australian Government provides funding for certain specialised medications under the Highly Specialised Drugs Program. Highly Specialised Drugs are medicines for the treatment of chronic conditions which, because of their clinical use or other special features, are restricted to supply through public and private hospitals having access to appropriate specialist facilities. To prescribe these drugs as pharmaceutical benefit items, medical practitioners are required to be affiliated with these specialist hospital units. A general practitioner or non-specialist hospital doctor may only prescribe Highly Specialised Drugs to provide maintenance therapy under the guidance of the treating specialist.

Benefits are available for the listed clinical indications only. There is no facility for individual patient approval for indications outside those listed.

To gain access to a Commonwealth funded drug under this program, a patient must attend a participating hospital and be a day admitted patient, a non-admitted patient or a patient on discharge, be under appropriate specialist medical care, meet the specific medical criteria and be an Australian resident in Australia (or other eligible person).

A patient will be required to pay a contribution for each supply of a highly specialised drug at a similar rate to the Pharmaceutical Benefits Scheme. Commonwealth subsidy is not available for hospital in-patients.

Reciprocal Health Care Agreement – Where a patient is entitled to be treated as an eligible person as a visitor from a country with which Australia has entered into a Reciprocal Health Care Agreement, the supply will be limited to the original prescription only. Repeat prescriptions for these patients are not permitted.

Private Hospitals – In addition to the above requirements, for Highly Specialised Drugs prescribed through private hospitals, claiming and approval of authority prescriptions is administered by Department of Human Services. Highly Specialised Drugs are authority required items. Medical practitioners must seek approval to prescribe these items as pharmaceutical benefits prior to their dispensing under the PBS. Approval of authority prescriptions by Department of Human Services may be obtained either by posting an Authority Prescription Form to Department of Human Services, or by using Department of Human Services' Authority Freecall service (1800 888 333). Prescribers must quote the provider number of the hospital when applying. Not more than two months’ supply (one month’s supply in the case of Clozapine), with provision for up to 5 repeats, will be authorised. Prescriptions for Highly Specialised Drugs can be dispensed by an approved private hospital’s dispensary or by a community pharmacy.

The remuneration rates for Highly Specialised Drugs prescribed through private hospitals comprise the normal PBS ready- prepared dispensing fee plus a mark-up ascertained as follows:

- 10% for drugs with a price ex-manufacturer of less than $40;
- $4 for drugs with a price ex-manufacturer of between $40 and $100;
- 4% for drugs with a price ex-manufacturer of between $100.01 and $1000;
- $40 for drugs with a price ex-manufacturer of greater than $1000.

Public Hospitals – For Highly Specialised Drugs prescribed through public hospitals, claiming and access to the program is administered by the States/Territories Health Departments. Prescriptions for Highly Specialised Drugs can be dispensed by public hospital pharmacies.

If you would like further information about the Highly Specialised Drugs Program, please contact your pharmacy, Department of Human Services (Ph: 132 290) or email the Australian Government Department of Health.